RecruitingPhase 2NCT05469165

Serotonin Receptor Blockers in Ischemic Mitral Regurgitation

Blocking the Effects of Serotonin to Prevent Ischemic Mitral Regurgitation: a Randomized Trial (CYPRO-MR)

Sponsor

Laval University

Enrollment

214 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.

Min Age: 18 YearsMax Age: 80 Years

Patients 18-80 years old with a 1st episode of STEMI with documented coronary obstruction.
Left ventricle ejection fraction (LVEF)<50% and mitral tenting area ≥ 4 cm2, OR LVEF ≤ 40% and inferior/posterior wall motion anomaly, OR LVEF≤30% and wall motion in any territory.

Inability to provide informed consent
Hemodynamic instability / cardiogenic shock / papillary muscle rupture
Prior mitral valve procedure/surgery
Permanent atrial fibrillation (limiting imaging and MR quantification)
Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)
More than mild valvular disease (other than mitral) at baseline
Planned cardiac surgery (CABG or valve intervention) within 3 months
Contraindications for MRI
Ongoing treatment with selective serotonin reuptake inhibitor (SSRI)
Chronic use of sedative medication
Ongoing or planned pregnancy
Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min
Neurocognitive disorder
Symptom or prior episode of urinary obstruction or glaucoma (relative contraindications for cyproheptadine)

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DRUGCyproheptadine 4 Mg Oral Tablet

Cyproheptadine treatment for 3 months

OTHERPlacebo

Placebo administration for 3months

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT05469165